← Back to catalogue
Turbo-Elite Laser Atherectomy Catheter
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 420-159510(k) K170059
Identity
- Trade Name
- Turbo-Elite Laser Atherectomy Catheter EUDAMEDFDA UDI
- Generic Name
- Atherectomy laser system beam guide-catheter, peripheral FDA UDI
- Device Name
- Turbo-Elite Laser Atherectomy Catheter EUDAMED
- Model / Reference
- 420-159 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 420-159 FDA UDI
- Primary DI / UDI-DI
- 00813132024765 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813132024765 EUDAMED
- FDA Product Code
- MCW FDA UDI
- EMDN Code
- C010402020699 PERIPHERAL ATHERECTOMY SYSTEMS - OTHER EUDAMED
- GMDN Term
- Atherectomy laser system beam guide-catheter, peripheral FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.4875 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 2.0 Millimeter FDA UDILength — 150 Centimeter FDA UDI
Turbo-Elite Laser Atherectomy Catheter by Spectranetics Corporation — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170059 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K250385 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00813132024765 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spectranetics Corporation
- EUDAMED SRN
- US-MF-000020669
- FDA Applicant
- Spectranetics, Inc.
- Authorised Representative
- Spectranetics International B.V. NL-AR-000001484
Sources (3)
- EUDAMED 9b44cd1a-fccd-45a9-a31e-f053c1b7e952 85 fields · synced Jun 19, 2026
- FDA UDI 33c8a3f1-db5c-4422-848b-5fdf97b6fbb6 36 fields · synced May 30, 2026
- FDA 510(k) K170059 1 fields · synced May 18, 2026